Waldenström's MacroglobulinemiaPhase 2BallondorNCT03697356
R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia
A Phase 2 study testing Lenalidomide, Bortezomib, Rituximab, Dexamethasone in people with Waldenström's Macroglobulinemia, run by Kosin University Gospel Hospital at 1 site in South Korea.
Trial summary
A multicenter prospective phase II study of rituximab combined, lenalidomide, dexamethasone followed by lenalidomide maintenance in patients with newly diagnosed Waldenström's macroglobulinemia (Ballondor trial) Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Waldenström's Macroglobulinemia
- What is being tested?
- Lenalidomide, Bortezomib, Rituximab, Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Mar 2019to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia
- Patients who meet criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's macroglobulinemia
- Male or female patients aged ≥19 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients must have measurable disease, IgM > 0.5g/dL
- Appropriate bone marrow, liver, and kidney function
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- Patients who are able to understand oral and written instructions and who are able to comply with all requirements
- Patients who provided agreement of subject consent (ICF) prior to initiation of clinical trial.
- Female patients had to be post-menopausal for ≥1 year, surgically sterile, or practicing an effective method of birth control (as described in the protocol), and have a negative serum beta-human chorionic gonadotropin or urine pregnancy test at screening; they also had to agree to continue using birth control measures for ≥6 months after terminating treatment. Male patients had to agree to use an acceptable method of contraception for the duration of the study.
Who cannot join
- Central nervous system involvement central nervous system (CNS) involvement by Waldenström's macroglobulinemia
- Patients who have received rituximab, lenalidomide, or bortezomib
- Patients who are allergic or hypersensitive to mouse (murine), chimeric, human or humanized proteins, lenalidomide, bortezomib
- One of the following labs or more:
- Absolute neutrophil count (ANC) <1,000 / μL
- Platelet count <75,000 cells / μL when not transfused
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- Serum AST / ALT> 3 times the upper limit of normal
- Renal failure requiring hemodialysis or peritoneal dialysis
- Patients with uncontrolled severe heart disease
- Patients who can not or do not want antithrombotic therapy
- Patient has more than Grade 2 peripheral neuropathy on clinical examination during the screening period
- Patient with a history of stroke or cerebral hemorrhage within 12 months bofore signing ICF
- Patients who have been diagnosed with a currently unadjusted severe infection
- Patients with known human immunodeficiency virus (HIV), hepatitis C infection
- Patients diagnosed with malignancy within 5 years before signing ICF
- Pregnant or lactating patients
- Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor
- Patients with acute diffuse invasive pulmonary disease and cardiovascular disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kosin University Gospel Hospital
Busan, Sue-gu, 60542
HoSup Lee, MD, PhD, 82-990-5820, hs52silver@gmail.com,hs3667@hanmail.net
Sujun Lee, 82-990-6107, gssj82@naver.com
About this study
Official title: A Multicenter Prospective Phase II Study of Rituximab Combined, Lenalidomide, Dexamethasone Followed by Lenalidomide Maintenance in Patients With Newly Diagnosed Waldenström's Macroglobulinemia
A multicenter prospective phase II study of rituximab combined, lenalidomide, dexamethasone followed by lenalidomide maintenance in patients with newly diagnosed Waldenström's macroglobulinemia (Ballondor trial)
Read the detailed description
Most patients with Waldenstrom's Macroglobulinemia are rare, and most studies are based on Phase II clinical studies, so the most effective regimen has not been established. However, in patients without experience of treatment with rituximab monotherapy targeting CD20 antigen expressed on lymphocytic cells, the response rate is reported to be approximately 25% -45%. Combined chemotherapy including rituximab is recommended as a primary treatment.
In Korea, there are few studies on Waldenstrom's Macroglobulinemia, and a relatively large number of patients have studied the data of 71 patients in 2014, retrospectively. In the present study, we found that the combined chemotherapy regimen with rituximab significantly improved the overall response rates. Bortezomib may also be effective in the treatment of Waldenstrom's Macroglobulinemia. Based on this, clinical trials of combined chemotherapy with rituximab or dexamethasone have been conducted and 80-90% reported However, lenalidomide 15mg alone was administered, lenalidomide was effective in Waldenstrom's Macroglobulinemia with a 29% overall response rate.
The authors concluded that the combination therapy of rituximab, bortezomib, lenalidomide, and dexamethasone is an effective treatment regimen that can improve the overall response rate including complete remission. Patients with Waldenstrom's Macroglobulinemia diagnosed in Korea we planned this study to evaluate the efficacy and safety of lenalidomide maintenance therapy with chemotherapy with chemotherapy including rituximab, bortezomib, lenalidomide, and dexamethasone
- Conditions
- Waldenström's Macroglobulinemia
- Being tested
- Lenalidomide, Bortezomib, Rituximab, Dexamethasone
- Medical subject headings
- Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide, Bortezomib, Rituximab, DexamethasoneDrug
step 1; R-VRD induction : rituximab, bortezomib, lenalidomide, and dexamethasone induction
- Rituximab 375 mg/m2 intravenous on day 1
- Bortezomib 1.3mg/m2 subcutaneous on day 1, 8, 15
- Lenalidomide 15mg p.o on day 1-21
- Dexamethasone 20 mg/m2 intravenous or p.o on day 1-4
Step 2 ; Maintenance Beginning 8 weeks after completion of induction therapy, patients receive lenalidomide 10mg once day 1-21 for 4 weeks. Treatment repeats every 1 months for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab&Bortezomib&Lenalidomide&Dexamethasone | Experimental | Rituximab\&Bortezomib\&Lenalidomide\&Dexamethasone Receives: Drug: Lenalidomide, Bortezomib, Rituximab, Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Response assessment in Waldenström macroglobulinaemia
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start6 Mar 2019
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenström's MacroglobulinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kosin University Gospel Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Sup Lee, Kosin University Gospel Hospital
- Investigators
- HoSup Lee, Principal investigator, KUGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697356
- Sponsor's protocol ID
- Ballondor
- Acronym
- Ballondor
- Status last verified
- Oct 2023
- First submitted
- 1 Oct 2018
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Phase II Study of Rituximab Combined, Lenalidomide, Dexamethasone Followed by Lenalidomide Maintenance in Patients With Newly Diagnosed Waldenström's Macroglobulinemia
- ClinicalTrials.gov ID
- NCT03697356
- Acronym / sponsor ID
- Ballondor / Ballondor
- Conditions
- Waldenström's Macroglobulinemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Kosin University Gospel HospitalUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter prospective phase II study of rituximab combined, lenalidomide, dexamethasone followed by lenalidomide maintenance in patients with newly diagnosed Waldenström's macroglobulinemia (Ballondor trial)
Detailed description
Most patients with Waldenstrom's Macroglobulinemia are rare, and most studies are based on Phase II clinical studies, so the most effective regimen has not been established. However, in patients without experience of treatment with rituximab monotherapy targeting CD20 antigen expressed on lymphocytic cells, the response rate is reported to be approximately 25% -45%. Combined chemotherapy including rituximab is recommended as a primary treatment.
In Korea, there are few studies on Waldenstrom's Macroglobulinemia, and a relatively large number of patients have studied the data of 71 patients in 2014, retrospectively. In the present study, we found that the combined chemotherapy regimen with rituximab significantly improved the overall response rates. Bortezomib may also be effective in the treatment of Waldenstrom's Macroglobulinemia. Based on this, clinical trials of combined chemotherapy with rituximab or dexamethasone have been conducted and 80-90% reported However, lenalidomide 15mg alone was administered, lenalidomide was effective in Waldenstrom's Macroglobulinemia with a 29% overall response rate.
The authors concluded that the combination therapy of rituximab, bortezomib, lenalidomide, and dexamethasone is an effective treatment regimen that can improve the overall response rate including complete remission. Patients with Waldenstrom's Macroglobulinemia diagnosed in Korea we planned this study to evaluate the efficacy and safety of lenalidomide maintenance therapy with chemotherapy with chemotherapy including rituximab, bortezomib, lenalidomide, and dexamethasone
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab&Bortezomib&Lenalidomide&Dexamethasone | Experimental | Drug: Lenalidomide, Bortezomib, Rituximab, DexamethasoneRituximab\&Bortezomib\&Lenalidomide\&Dexamethasone |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia
- Patients who meet criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's macroglobulinemia
- Male or female patients aged ≥19 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients must have measurable disease, IgM > 0.5g/dL
Key exclusion criteria (18 listed)
- Central nervous system involvement central nervous system (CNS) involvement by Waldenström's macroglobulinemia
- Patients who have received rituximab, lenalidomide, or bortezomib
- Patients who are allergic or hypersensitive to mouse (murine), chimeric, human or humanized proteins, lenalidomide, bortezomib
- One of the following labs or more:
- Renal failure requiring hemodialysis or peritoneal dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenalidomide, Bortezomib, Rituximab, Dexamethasonestep 1; R-VRD induction : rituximab, bortezomib, lenalidomide, and dexamethasone induction * Rituximab 375 mg/m2 intravenous on day 1 * Bortezomib 1.3mg/m2 subcutaneous on day 1, 8, 15 * Lenalidomide 15mg p.o on day 1-21 * Dexamethasone 20 mg/m2 intravenous or p.o on day 1-4 Step 2 ; Maintenance Beginning 8 weeks after completion of induction therapy, patients receive lenalidomide 10mg once day 1-21 for 4 weeks. Treatment repeats every 1 months for 24 months. | Drug | Rituximab&Bortezomib&Lenalidomide&Dexamethasone |
Primary outcome
survival
Time frame: 2 years
Response assessment in Waldenström macroglobulinaemia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HoSup Lee principal investigator
KUGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide, Bortezomib, Rituximab, Dexamethasone in people with Waldenström's Macroglobulinemia, run by Kosin University Gospel Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HoSup Lee, MD, PhD (+82519005820, hs3667@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.